Late restenosis following sirolimus-eluting stent implantation

Despite encouraging results from randomized trials, concerns exist about long-term results of sirolimus-eluting stent implantation. We sought to determine whether in-stent restenosis occurring >1 year ("late") after sirolimus-eluting stent implantation is a real clinical entity. We analyzed data on all sirolimus-eluting stents implanted in our institution before March 2003. During the study period 928 lesions in 433 patients were treated. Angiographic follow-up was performed in 306 patients (70.6%) with 679 lesions (73.2%). Angiography after 1 year was performed only in symptomatic patients. We considered restenosis "early" if it occurred during the first year and late if after 1 year. Late restenosis required demonstration of a widely patent stent at 6 to 9 months, with repeat angiography after 1 year demonstrating restenosis. Restenosis occurred in 160 lesions overall (23.5%). Of the 31 (4.6%) that were documented after 1 year, 13 were excluded from analysis due to absence of 6- to 9-month angiography; the remaining 18 (2.6%, 1.7 to 4.2) fulfilled our criteria for late restenosis (median time of documentation 607 days, interquartile range 511 to 923). In conclusion, late restenosis is an infrequent but real entity; its existence implies we should not discount the possibility of restenosis as the cause of symptoms that develop >1 year after sirolimus-eluting stent implantation.     

Drug eluting stents: focus on Cypher sirolimus-eluting coronary stents in the treatment of patients with bifurcation lesions

Coronary bifurcations represent a challenging lesions subset and account for up to 15% of all current PCI. Regardless of the stenting technique used, however, restenosis rate after bare metal stent (BMS) is high, especially at the ostium of the side branch (SB). The introduction of drug-eluting stent (DES) has remarkably improved the outcome in bifurcation lesions compared to BMS, resulting in lower adverse events and main branch (MB) restenosis rates. Furthermore, although the "provisional" stenting technique (second stent on the SB placed, after the MB stenting, only in case of suboptimal or inadequate result) remained the prevailing approach, several two-stent techniques emerged (crush) or were re-introduced (V, T, culottes) to allow stenting in both branches when needed. At the present time, only few randomized studies and some observational reports specifically addressed the issue of bifurcation lesion treatment with sirolimus-eluting stents (SES). It is still not clear yet which is the better strategy between the provisional approach and stenting both branches when dealing with a bifurcation lesion which has a stenosis in the SB suitable for stenting. Moreover, no study has so far addressed which is the best strategy to use among the several techniques reported in the literature when both branches are intentionally stented from the outset. Finally, the introduction of dedicated stents for different types of bifurcations, with specific stent designs to provide good deliverability, secured access to the side branch, complete coverage of the lesion site without double/triple layers of stent struts, thus incorporating the benefits of drug elution and ensuring drug availability to all diseased surfaces, may further facilitate the conquest of one of the most challenging areas in interventional cardiology.     

Gadolinium-based contrast agents and nephrotoxicity in patients undergoing coronary artery procedures.

OBJECTIVE: We tested whether gadolinium-based contrast agent is less nephrotoxic than iodinated-contrast media. BACKGROUND: Iodinated contrast agents are nephrotoxic. Some data suggest that gadolinium-based contrast agent may be less nephrotoxic than iodinated-contrast media. METHODS: Twenty-five consecutive patients with chronic renal insufficiency (creatinine concentration > or = 2.0 mg/dl and/or clearance < or = 40 ml/min), referred to our institution for coronary procedures, were assigned to receive gadolinium-based contrast agents, a solution of gadolinium chelates diluted 3:1 by iso-osmolality contrast media (Gadolinium-based group). A control group of 32 patients with comparable clinical characteristics and treated with iodinated iso-osmolality contrast agent alone (Iodinated-based group) was selected from our database and compared with the Gadolinium-based group. In all cases, prophylactic administration of 0.45% saline intravenously and NAC (1200 mg orally twice daily) was used. RESULTS: Baseline creatinine levels and creatinine clearance were similar in the 2 groups (Gadolinium-based group = 2.30 [IQR: 2.01-2.68] mg/dl and 33 +/- 13 ml/min; Iodinated-based group = 2.24 [IQR: 2.05-2.65] mg/dl and 30 +/- 10 ml/min; P > 0.05 for all). Increase of at least 0.5 mg/dl of the creatinine concentration 48 hr after the procedure occurred in 7/25 (28%) patients in the Gadolinium-based group and in 2/32 (6.5%) patients in the Iodinated-based group (P = 0.034; OR = 4.48; 95% CI = 1.01-19.17). Renal failure requiring temporary dialysis occurred in 2 (8%) patients in the Gadolinium-based group and in none in the Iodinated-based group (P = 0.19). CONCLUSIONS: The strategy of gadolinium-based contrast agent administration does not seem to reduce the rate of CAN, as compared to the iodinated iso-osmolality contrast agent in patients with chronic renal insufficiency.     

Comparable clinical outcomes with paclitaxel- and sirolimus-eluting stents in unrestricted contemporary practice.

OBJECTIVES: This study was designed to compare the outcomes of paclitaxel-eluting stents (PES) and sirolimus-eluting stents (SES) in a contemporaneous cohort of real-world patients. BACKGROUND: A number of randomized comparisons of PES and SES have shown unequivocal advantages for SES in angiographic end points such as late loss. However, the data on clinical outcomes are less consistent. METHODS: All consecutive patients successfully treated with only SES or PES in de novo native vessel lesions between March 2003 and March 2005 were analyzed. Our end points were major adverse cardiac events (MACE), a composite of death, myocardial infarction (MI), target vessel revascularization (TVR), and target lesion revascularization (TLR). We also analyzed late loss and angiographic restenosis. RESULTS: There were 609 patients (1,064 lesions) treated with PES and 674 patients (1,205 lesions) treated with SES. Diabetes mellitus was present in 26.8% of patients and multivessel disease in 75% of patients. Bifurcations made up 16.3% of lesions, chronic occlusions 9.5%, left main 4.8%, and American Heart Association/American College of Cardiology type B2/C 75.4%. Despite a higher late loss in the PES group (p = 0.0001), there were no differences in angiographic restenosis (PES 18% vs. SES 17.8%, p = 0.95), TLR (PES 11.9% vs. SES 11%, p = 0.47), or MACE (PES 21.3% vs. SES 21.1%, p = 0.95). The relative risk of MACE for the PES group was 1.02 (95% confidence interval [CI] 0.78 to 1.33). Multivariable analysis confirmed the lack of association of stent type with MACE (odds ratio 1.03 [95% CI 0.77 to 1.38], p = 0.83) and TLR (odds ratio 1.08 [95% CI 0.81 to 1.44], p = 0.61). CONCLUSIONS: In this complex cohort, both stent platforms demonstrated similar clinical outcomes despite different late loss.